1. Field of the Invention
The present invention is in the field of formulations of β-carotene, and methods of using such formulations. More particularly, the present invention relates to clear micellized formulations of β-carotene adapted for treating leukoplakia in human patients, and to the process of such treatment.
2. Brief Description of the Prior Art
β-carotene is a well known naturally occurring substance and has been used in the prior art in nutritional supplements, vitamin or vitamin related formulations, as well as in other formulations applied to the human skin. U.S. Pat. No. 4,572,915 describes clear, micellized aqueous formulations of several fat soluble vitamins, essential nutrients herb oils and other fat soluble pharmaceutical agents, including a formulation of β-carotene. The formulations of U.S. Pat. No. 4,572,915 are to be ingested by humans as nutritional and/or vitamin supplements.
Leukoplakia is a disease characterized by formation of white or off-white colored lesions in the mouth that have the potential of developing into oral cancer. It follows that partial or total elimination of the pre-malignant leukoplakia lesions is medically desirable, and may well serve as a life-saving measure by preventing the development of potentially disfiguring or fatal oral cancer. The present invention provides β-carotene formulation which is specifically adapted for treating leukoplakia lesions with highly favorable results.